Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients

STATUS

Recruiting
participants needed

30
sponsor

Corvus Pharmaceuticals, Inc.

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Updated on 19 February 2024

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cancer

monoclonal antibodies

oximetry

covid-19

SARS

nasopharyngeal swab

nasal swab

acute respiratory syndrome (sars)

Summary

This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients.

Details

Condition	Covid 19
Age	18-100 years
Treatment	CPI-006
Clinical Study Identifier	NCT04464395
Sponsor	Corvus Pharmaceuticals, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test
	Hospitalized and have stable mild to moderate symptoms of COVID-19
	Blood oxygen saturation of at least 92% on 5L/min supplemental oxygen
	Patients with cancer must be in remission or have stable, controlled disease and may be actively receiving drugs or biologics not deemed by the investigator to likely affect immune response
	Women must not be of child bearing potential or agree to use contraceptive guidance for 6 weeks
Exclusion Criteria
	Patients receiving previous invasive mechanical ventilation or non-invasive ventilation (CPAP, BiPAP) for COVID-19 illness
	Patients hospitalized >7 days prior to receiving study intervention
	Other diseases or conditions that are not controlled
	On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory
	Patients with autoimmune disease must be controlled on non immunosuppressive or immune modifying agents
	Have received cytotoxic, immunosuppressive or immunomodulatory agents within past 3 months
	Patients receiving experimental therapies that are immunosuppressive
	Patients receiving non-immuno-suppressive experimental therapies within 7 days prior to receiving CPI-006
	Patients receiving convalescent plasma within past 30 days
	Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30 days

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Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients